Opinions on clinical trial

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Opinions on clinical trial

Postby patientx » Sat Sep 20, 2008 2:12 pm

Hi all,

I've been recently diagnosed (about a month and a half ago), and was told to pick a DMD. I live near 2 fairly well known hospitals with MS centers, and looked into what trials they had. One hospital has several trials for which they are recruiting. I shied away from the trials which have a placebo group, and came up with two possibilities. One is the Campath trial, but unfortunately it is the version for people who have had a relapse while using one of the standard meds. So, I don't qualify for this one (yet). Another trial they have is the CombiRX study, which combines Avonex and Copaxone. In the study, 25% get Avonex alone, 25% get Copaxone alone, and 50% get both (though everyone has to inject 8 times a week).

I wanted to participate in a study for altruistic reasons, and the CombiRX seems relatively safe (and I wouldn't be getting no treatment). What I'm wondering is, does anyone think this study is worthwhile? I know many people are down on the ABCRs, and with only a 30% efficacy rate, I can see why. I wonder what really will be accomplished with this study. And, although I would be getting the medicines free, it would be easier for me to just to get Rebif and inject 3 times/week. It looks like my insurance will be pretty good about the costs of the drugs.

Any opinions are welcome. Thanks.
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Postby rainer » Sat Sep 20, 2008 3:07 pm

I would take the combination study. Non-placebo trials are still somewhat rare.

8 shots sounds worse then 3 obviously but you're body may react otherwise. And if the study is too rough on you, find out what dropping out and getting back on rebif would entail.
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Re: Opinions on clinical trial

Postby CureOrBust » Sat Sep 20, 2008 3:18 pm

patientx wrote:One is the Campath trial, but unfortunately it is the version for people who have had a relapse while using one of the standard meds.
From what i understand there are two campath trials current or planned. The first is the one you mentioned, where you have had to of been on DMD for at least 6 months. The other is for "treatment naive" patients. My neuro's research assist was going to run the trials, but not for some time, however she knew of another centre that was recruiting for them, and gave me a contact. Check another centre, ask the first if they know of another, or even call genzyme.

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I don't know how the two trials are actually run, but i would expect you will know if your in the "placebo" group. If you opt to pull out of the trial, no one is going to reject a request for DMD.
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Postby patientx » Sun Sep 21, 2008 10:37 am

Thanks for the replies.

From what I understand, a person can drop out of any trial at any time, and is not required to give a reason. So, if I participated in a trial, I don't think this would affect my going to a normal DMD routine, if I needed to drop out for some reason.

And I checked for locations that were running the "treatment naive" study for Campath. Unfortunately, I didn't find any that were relatively close to where I live.

My question regarding the CombiRX study, though, is does anyone see any value in this study? By completing this study would anyone with MS really be helped?
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Postby cheerleader » Sun Sep 21, 2008 11:10 am

Avonex and Copaxone modulate the immune system in different ways: Avonex is an interferon and limits immune response and copaxone is a myelin-based protein which serves as decoy and keeps naive t-cells from turning inflammatory. Combining them would give the immune system a one-two punch, and if the result is better than one alone, this would be very valuable info for doctors and patients.

My husband is a copaxone "responder" and has done well with his therapy, but many people do not respond with copaxone and need to move on to interferons. It would be valuable to see if the myelin-based protein decoy could work even better with a beta interferon. Your altruistic impetus is greatly appreciated, patient x.
Wishing you well,
AC
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Postby Lyon » Sun Sep 21, 2008 11:20 am

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Postby patientx » Mon Sep 22, 2008 5:54 am

But researchers must be starting with some hypothesis they are trying to prove. I would like to think, in the particular instance of the CombiRX trial, that it's a bit more scientific than just thinking "hey, let's try this combination now." I came across one old post on this site that wondered if doctors would eventually prescribe both drugs, thereby doubling the drug manufacturers revenues. A bit cynical, but I have to admit I've wondered the same thing. But maybe these are questions for the trials coordinators.

As is evident from my postings, I've been trying to talk myself into participating. Thanks again for all the responses.


Mike
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Postby gibbledygook » Mon Sep 22, 2008 6:17 am

Beta interferon was originally developed as a cancer drug and was used as such for many years before the pharmaceutical companies decided to give it a whirl with MS. I strongly suspect that they are merely trying to maximise their revenues whilst the patents last.
3 years antibiotics, 06/09 bilateral jug stents at C1, 05/11 ballooning of both jug valves, 07/12 stenting of renal vein, azygos & jug valve ballooning,
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Postby MaggieMae » Mon Sep 22, 2008 10:54 am

I also wonder how hard taking two of this medications would be on your body. Many people have flu symptoms, etc with just one medication.
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Postby Lyon » Mon Sep 22, 2008 12:29 pm

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Postby cheerleader » Mon Sep 22, 2008 4:09 pm

Here's da facts folks....you all know by now I'm a nit-picker (or knit-picker ala Gainsy) :) bien sur!

The CombiRx trial, is in phase 3. The first large-scale clinical study evaluating the combination of IM IFN β-1a and glatiramer acetate in RRMS, is currently under way at 80 centers in North America. Approximately 1,000 patients are being randomized to receive the combination (IM IFN β-1a 30 µg once weekly plus SC glatiramer acetate 20 mg once daily) or either agent alone for 36 months. The primary objective is to compare relapse rates in the 3 treatment groups. A previous pilot study of this combination suggested that it was safe and warranted further investigation.

I don't think the CombiRX trial, which began in 2005, would still be cranking along unless some folks were benefitting. I am not anti or pro pharma...no agenda here. As I said in my earlier post, these two medicines affect different aspects of the immune system...using them together adds a one/two punch- myelin-based protein decoy and interferon. The trial is being sponsored by the NIH, and is still recruiting. It means 8 shots a week, one more than just copaxone.
factually yours,
AC
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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